DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis

Information source: InSite Vision
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blepharitis

Intervention: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) (Drug); Azasite (Drug); Dexamethasone (Drug); Vehicle (Other)

Phase: Phase 3

Status: Completed

Sponsored by: InSite Vision


The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSiteŽ alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.

Clinical Details

Official title: A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Clinical Resolution

Recurrence of Clinical Signs and Symptoms


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.

- Signature of the subject or legally authorized representative on the Informed Consent


- Are willing and able to follow all instructions and attend all study visits.

- Are willing to avoid disallowed medication for the duration of the study.

- If female is of childbearing potential, agree to and submit a urine sample for

pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.

- Additional inclusion criteria also apply.

Exclusion Criteria:

- Have known sensitivity or poor tolerance to any component of the Investigational


- Have an acute ocular infection (bacterial, viral or fungal) or active ocular

inflammation other than Blepharitis in the study eye.

- Have used topical corticosteroid medications or topical ophthalmic solutions that the

investigator feels may interfere with the study parameters.

- Have used any non-diagnostic topical ophthalmic solutions in the study eye.

- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a

positive urine pregnancy test.

- Currently suffer from alcohol and/or drug abuse.

- Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an

investigational drug or device.

- Have a condition or a situation which, in the Investigator's opinion, may put the

subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

- Additional exclusion criteria also apply.

Locations and Contacts

Arizona Eye Center, Chandler, Arizona, United States

Arizona Center for Clinical Trials LLC, Phoenix, Arizona, United States

Cornea Consultants of Arizona, Phoenix, Arizona, United States

Lugene Eye Institute, Glendale, California, United States

United Medical Research Institute, Inglewood, California 90301, United States

Macy Eye Center, Los Angeles, California 90048, United States

North Valley Eye Medical Group, Inc., Mission Hills, California, United States

Eye Research Foundation, Newport Beach, California, United States

North Bay Associates, Inc., Petaluma, California, United States

Martel Eye Medical Group, Rancho Cordova, California 95670, United States

Shasta Eye Medical Group, Inc., Redding, California, United States

San Diego Eye and Laser Center, San Diego, California 92123, United States

West Coast Eye Care Associates, San Diego, California, United States

Florida Eye Microsurgicial Institute, Inc., Boynton Beach, Florida, United States

ZASA Clinical Research, LLC, Boynton Beach, Florida, United States

Magruder Eye Institute, Orlando, Florida, United States

Vision Eye Care Center, Palm Springs, Florida, United States

International Research Center, Tampa, Florida, United States

Richard Eiferman, MD, Louisville, Kentucky, United States

Lakeview Optical, Gretna, Louisiana, United States

Center for Sight, Inc., Fall River, Massachusetts 02720, United States

Tauber Eye Center, Kansas City, Missouri, United States

Ophthalmology Associates, St. Louis, Missouri, United States

Comprehensive Eye Care Ltd, Washington, Missouri, United States

Abrams Eye Institute, Las Vegas, Nevada, United States

Nevada Eye Care Professionals, Las Vegas, Nevada, United States

Eye Care Associates of Nevada, Sparks, Nevada, United States

David Ringel, OD PA, Sewell, New Jersey, United States

Ophthalmic Consultants of Long Island, Lynbrook, New York, United States

Ophthalmic Consultants of Long Island, Rockville Centre, New York, United States

Ophthalmic Consultants of Long Island, Valley Stream, New York, United States

South Shore Eye Care, Wantagh, New York, United States

Charlotte Eye Ear Nose & Throat Associates, P.A., Charlotte, North Carolina, United States

Mundorf Eye Center, Charlotte, North Carolina, United States

James Branch, MD, Winston-Salem, North Carolina, United States

Eye Care Associates of Greater Cincinnati, Inc., Cincinnati, Ohio, United States

Eye Care Associates of Greater Cincinnati, Inc., Fairfield, Ohio, United States

Eye Care Associates of Greater Cincinnati, Inc., Madeira, Ohio, United States

Roseburg Research Associates, LLC, Roseburg, Oregon 97471, United States

Philadelphia Eye Associates, Philadelphia, Pennsylvania, United States

Research Across America @ Wyomissing Optometric Center Inc, Wyomissing, Pennsylvania, United States

Total Eye Care, PA, Memphis, Tennessee, United States

David Shulman, MD, San Antonio, Texas, United States

Sun Research Institute, San Antonio, Texas, United States

Daynes Eye and Lasik, Salt Lake City, Utah 84103, United States

Additional Information

Starting date: October 2011
Last updated: April 16, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017